Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-17

Study Completion Date

2018-11-21

Brief Summary

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This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.

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Detailed Description

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The primary objective of this study was to assess the treatment duration in the real life in 2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by 600 mg twice daily IV/PO (intravenous/per oral) linezolid.

Conditions

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Skin Disease, Infectious

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tedizolid

Hospitalized ABSSSI patients treated with tedizolid

Tedizolid (Sivextro, BAY1192631)

Intervention Type DRUG

Antibiotic

Linezolid

Hospitalized ABSSSI patients treated with linezolid

Linezolid

Intervention Type DRUG

Antibiotic

Interventions

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Tedizolid (Sivextro, BAY1192631)

Antibiotic

Intervention Type DRUG

Linezolid

Antibiotic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult female and male in-patients with clinical diagnosis compatible with ABSSSI (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by Gram positive bacteria (with or without laboratory confirmation).
* Patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician's routine treatment practice.
* Signed informed consent.

Exclusion Criteria

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients who have been enrolled in this study before.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No